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FDA takes steps to limit the misuse and abuse of prescription drugs

Prescription drugs, including opioid analgesics, are an important component of modern pain management; however, because they tend to produce euphoria in addition to pain relief, they can often be misused and abused.

The FDA has undertaken several efforts to help clinicians manage this widespread issue by instating guidelines to better understand the abuse potential of new drugs, and make drugs currently on the market less likely to be abused through the approval of abuse-deterrent formulations (ADFs). It is stated that a broad range of CNS drugs require Human Abuse Potential (HAP) studies, also known as Human Abuse Liability (HAL) studies, to evaluate the abuse liability of drugs in development and to determine the relative risk of abuse before a drug comes to market.

Altasciences' Supporting HAP Case Study

Altasciences’ full-service capabilities for abuse potential studies provide a one-stop solution in support of HAP studies for new chemical entities (NCEs) or ADFs. We have conducted close to 40 HAP/substance abuse studies for pharmaceutical/biotech companies in both the U.S. and Canada in the last 5 years. Our research includes studies for stimulants, opioids, cannabinoids, and sedative hypnotics.

Our robust database of participants has made rapid enrollment and retention some of our greatest strengths, allowing us to overcome recruitment challenges, which is one of the major obstacles for studies of this nature due to the unique patient populations and confinement periods. In addition, our adaptive, secure and limited access clinical pharmacology units (CPUs) are specially designed to sequester the more challenging subject populations involved in HAP studies.

Study Purpose

To evaluate Mirogabalin as a well-tolerated novel α2δ ligand with low abuse potential.

Methods

The HAP study was designed as 2 independent studies intended to evaluate the abuse potential of Mirogabalin versus a) placebo and Diazepam, and b) placebo and Pregabalin, in recreational drug users. Each study was divided into 2 parts: a qualification phase and an assessment phase. The study comparing Mirogabalin to Diazepam was conducted as a randomized, placebo and active-controlled crossover study involving 38 recreational polydrug users who had a history of CNS depressant use. In evaluating the abuse potential of Mirogabalin against Pregabalin, a single ascending dose study in 24 subjects was first conducted to evaluate 3 doses of Mirogabalin. The data from this study was then used to select the doses to be used in the abuse potential study with 56 participants, which had a similar design to the Diazepam study.

Results

In both studies, the planned therapeutic dose of Mirogabalin did not have maximal Drug Liking scores different from the placebo. These scores were also found to be significantly less than therapeutic doses of Diazepam and Pregabalin. The overall incidence of adverse events of Mirogabalin was comparable to, or lower than the placebo in both studies.

Conclusion

The studies showed that a therapeutic dose of Mirogabalin is a safe and well-tolerated α2δ ligand with low potential for abuse in recreational polydrug users.